COMMISSION IMPLEMENTING REGUL ATION (EU) 2021/968 
of 16 June 2021
concer ning the renewal of the author isation of zinc chelate of hydro xy analogue of methionine as a 
feed additiv e for all animal species, and repealing Regulation (EU) No 335/2010 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng rega rd to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 Sept ember 2003 on 
additives for use in animal nutr ition (1), and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provid es for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting and renewing such author isation.
(2) Zinc chelate of hydro xy analogue of methionine was author ised for 10 years as a feed additive for all animal species 
by Commission Regulation (EU) No 335/2010 (2).
(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of 
the author isation of zinc chelat e of hydroxy analogue of methionine as feed additive for all animal species in the 
additive catego ry ‘nutr itional additives ’. The application was accompanied by the particulars and documents 
required under Article 14(2) of Regulation (EC) No 1831/2003.
(4) It results from the opinion of the European Food Safet y Author ity (‘the Author ity’) of 18 November 2020 (3)that, 
under the proposed conditions of use, zinc chelat e of hydro xy analogue of methionine does not have an adverse 
effect on animal health, consumer safet y or the environment. The Author ity also concluded for the additive a risk 
for the user by inhalation and that it is a skin sensitizer . Theref ore, the Commission considers that appropr iate 
prote ctive measures should be taken to prevent adverse effects on human health, in particular as regar ds the users 
of the additive. The proof of the efficacy of the additive, on which the initial author isation was based, withstands in 
a renewal procedure. The Author ity also verified the repor t on the method of analysis of the feed additive in feed 
submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5) The assessment of zinc chelate of hydro xy analogue of methionine shows that the conditions for author isation, as 
provid ed for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. According ly, the author isation of this 
additive should be renewed.
(6) As a consequence of the renewal of the author isation of zinc chelate of hydroxy analogue of methionine as feed 
additive, Regulation (EU) No 335/2010 should be repealed.
(7) The author isation holder signalled some modifi cations in the manufact uring process. Since safet y reasons do not 
require the immediate application of these modifi cations to the conditions of author isation for zinc chelat e of 
hydroxy analogue of methionine, it is appropr iate to allow a transitional period for interest ed parties to prepare 
themselves to meet the new requirements resulting from the renewal of the author isation.
(8) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
(1)OJ L 268, 18.10.2003, p. 29.
(2)Commission Regulation (EU) No 335/2010 of 22 Apr il 2010 concer ning the author isation of zinc chelat e of hydro xy analogue of 
methionine as a feed additive for all animal species (OJ L 102, 23.4.2010, p. 22).
(3)EFSA Journal 2020;18(12):6337.EN Offi cial Jour nal of the European Union 17.6.2021                                                                                                                                         L 214/45  HAS ADOPTED THIS REGUL ATION:
Article 1
The author isation of the additive specifi ed in the Annex, belonging to the additive categor y ‘nutr itional additives ’and to the 
functional group ‘compounds of trace elements ’, is renewed subject to the conditions laid down in that Annex.
Article 2
1. Zinc chelat e of hydroxy analogue of methionine and premixtures containing this additive, whic h are produced and 
labelled before 7 Januar y 2022 in accordance with the rules applicable before 7 July 2021 may continue to be placed on 
the mark et and used until the existing stoc ks are exhaust ed.
2. Feed mat erials and compo und feed containing zinc chelat e of hydroxy analogue of methionine, whic h are produced 
and labelled before 7 July 2022 in accordance with the rules applicable before 7 July 2021 may continue to be placed on 
the mark et and used until the existing stoc ks are exhaust ed if they are intended for food-producing animals.
3. Feed mat erials and compo und feed containing zinc chelat e of hydroxy analogue of methionine, whic h are produced 
and labelled before 7 July 2023 in accordance with the rules applicable before 7 July 2021 may continue to be placed on 
the mark et and used until the existing stoc ks are exhaust ed if they are intended for non-f ood-producing animals.
Article 3
Regulation (EU) No 335/2010 is repealed.
Article 4
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 June 2021 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 214/46                                                                                                                                         17.6.2021  ANNEX 
Identif i-
cation 
number 
of the 
additiv eName of the 
holder of 
author isationAdditiv eComposition, chemical formula, descr iption, 
analytical methodSpecies or 
categor y 
of animalMaximum 
ageMinimum 
contentMaximum  
content
Other provisionsEnd of 
period of 
author isa-
tionContent of element (Zn) in  
mg/kg of complete feed with a 
moistu re content of 12 %
Categor y: nutr itional additiv es. Functional group: compounds of trace elements
3b610 - Zinc chelate of 
hydroxy 
analogue of 
methionineCharacter isation of the additiv e:
Zinc chelat e of hydroxy analogue of 
methionine containing 17 % zinc and 79 % 
(2-h ydro xy-4-methylthio) butanoic acid.
Maximum content of nick el: 1,7 ppm.
Solid form.All species - - Dogs and cats: 200 
(total)
Salmonids and milk 
replacers for calves: 
180 (total)
Piglets, sows, 
rabbits and all fish 
other than 
salmonids: 150 
(total)
Other species and 
cate gories: 120 
(total)1.The additive shall be 
incor porated into feed 
in the form of a pre­
mixture.
2.Zinc chelat e of hydro ­
xy analogue of 
methionine may be 
placed on the mark et 
and used as an additive 
consisting of a pre­
paration.
3.For users of the addi ­
tive and premixtures, 
feed business opera ­
tors shall establish op­
erational procedures 
and appropr iate orga­
nisational measures to 
address the potential 
risks by inhalation, 
dermal contact or eyes 
contact, in particular 
due to the conte nt of 
heavy metals includ ­
ing nick el. Where risks 
cannot be reduced to 
an acceptable level by 7.7.2031
Analytical method (1):
For the quantifi cation of the hydroxy 
analogue of methionine content in the feed 
additive:
— Titrimetr y, poten tiometr ic titration after 
oxidation reduction reaction;
For the quantif ication of total zinc in the feed 
additive:
—Inductively coupled plasma atom ic emis ­
sion spectrometr y, ICP-AES (EN 15510 or 
EN 15621) or
— Atomic absor ption spectrometr y, AAS 
(ISO 6869)
For the quantifi cation of total zinc in 
premixtures:
—Inductively coupled plasma atom ic emis ­
sion spectrometr y, ICP-AES (EN 15510 or 
EN 15621) or
— Atomic absor ption spectrometr y, AAS 
(ISO 6869) or
—Inductively coupled plasma mass spectro ­
metr y, ICP-MS (EN 17053);EN Offi cial Jour nal of the European Union 17.6.2021                                                                                                                                         L 214/47  these procedures and 
measures, the additive 
and premixtures shall 
be used with appropr i­
ate personal protect ive 
equipment.For the quantifi cation of total zinc in feed 
mat erials and compo und feed:
—Inductively coupled plasma atom ic emis ­
sion spectrometr y, ICP-AES (EN 15510 or 
EN 15621) or
— Atomic absor ption spectrometr y, AAS 
(Commission Regulation (EC) 
No 152/2009 (Annex IV-C) or ISO 
6869) or
—Inductively coupled plasma mass spectro ­
metr y, ICP-MS (EN 17053).
(1)Details of the analytical methods are avail able at the follo wing address of the Reference Laboratory : https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-repor tsEN Offi cial Jour nal of the European Union L 214/48                                                                                                                                         17.6.2021